Supply Chain

Packaging Operations

Packaging facilities at Genzyme Waterford include two high-speed bottle filling, labelling and cartoning lines to support our tablet packaging requirements. These lines are responsible for the packaging of phosphate binder products Renagel and Renvela. There is a third line focused on packaging of Renvela sachet dosage forms.

The facility also contains a high speed vial labelling and cartoning line which is dedicated to the products processed in the Fill Finish facility.

The Packaging department has recently been expanded to incorporate a new highly automated line for future Genzyme products. This line will be focused on packaging of sachet dosage forms.

Manufacturing team members focus on the processing and packaging of our products in line with cGMP (current good manufacturing practices) requirements. These operations are undertaken in state-of-the-art facilities with a high focus on ensuring the quality of the products for our patients is maintained.

The Manufacturing Maintenance team’s key responsibilities include the support of the Manufacturing teams in the various areas by undertaking equipment preventative and predictive maintenance, troubleshooting as well as continuous improvement projects.

Process Engineering teams support each area through ongoing monitoring, troubleshooting and improvement of our production and packaging process. Furthermore, the teams work closely with our Development and Project Engineering teams in the introduction of new products and/or equipment to the site.

New Product Introduction

New Product Introduction (NPI) is responsible for the program management of Technology Transfer of Products and process knowledge between development and manufacturing or between manufacturing sites

Categories of Technology Transfer

Development scale to commercial scale for new product introduction

Transfer of marketed products

Existing commercial product and associated analytical methods

Site to Site from one manufacturing or packaging site to another site

Line to Line transfer of an existing product from one specified equipment train (such as a filling line/lyophiliser or tableting suite)

NPI is carried out using a stage gate-process consisting of a series of defined phases. For each NPI a program team is defined with a dedicated Program Lead as appropriate and team members from all departments across the site. The program team are responsible from Project Proposal to Regulatory Approval & commercial Manufacturing preparation.